50419-325-14 |
50419-325 |
HUMAN PRESCRIPTION DRUG |
Gadavist |
gadobutrol |
INJECTION |
INTRAVENOUS |
20110315 |
20260131 |
NDA |
NDA201277 |
Bayer HealthCare Pharmaceuticals Inc. |
GADOBUTROL |
604.72 mg/mL |
2 CARTON in 1 BOX (50419-325-14) / 5 BOTTLE, GLASS in 1 CARTON / 30 mL in 1 BOTTLE, GLASS |
50419-325-15 |
50419-325 |
HUMAN PRESCRIPTION DRUG |
Gadavist |
gadobutrol |
INJECTION |
INTRAVENOUS |
20110315 |
20260330 |
NDA |
NDA201277 |
Bayer HealthCare Pharmaceuticals Inc. |
GADOBUTROL |
604.72 mg/mL |
10 BOTTLE, GLASS in 1 BOX (50419-325-15) / 65 mL in 1 BOTTLE, GLASS |
50419-325-18 |
50419-325 |
HUMAN PRESCRIPTION DRUG |
Gadavist |
gadobutrol |
INJECTION |
INTRAVENOUS |
20110315 |
N/A |
NDA |
NDA201277 |
Bayer HealthCare Pharmaceuticals Inc. |
GADOBUTROL |
604.72 mg/mL |
2 CARTON in 1 BOX (50419-325-18) / 5 BOTTLE, GLASS in 1 CARTON / 30 mL in 1 BOTTLE, GLASS |
50419-325-19 |
50419-325 |
HUMAN PRESCRIPTION DRUG |
Gadavist |
gadobutrol |
INJECTION |
INTRAVENOUS |
20110315 |
N/A |
NDA |
NDA201277 |
Bayer HealthCare Pharmaceuticals Inc. |
GADOBUTROL |
604.72 mg/mL |
10 BOTTLE, GLASS in 1 BOX (50419-325-19) / 65 mL in 1 BOTTLE, GLASS |
50419-325-73 |
50419-325 |
HUMAN PRESCRIPTION DRUG |
Gadavist |
gadobutrol |
INJECTION |
INTRAVENOUS |
20210211 |
N/A |
NDA |
NDA201277 |
Bayer HealthCare Pharmaceuticals Inc. |
GADOBUTROL |
604.72 mg/mL |
30 mL in 1 BOTTLE, GLASS (50419-325-73) |
50419-325-74 |
50419-325 |
HUMAN PRESCRIPTION DRUG |
Gadavist |
gadobutrol |
INJECTION |
INTRAVENOUS |
20210211 |
N/A |
NDA |
NDA201277 |
Bayer HealthCare Pharmaceuticals Inc. |
GADOBUTROL |
604.72 mg/mL |
65 mL in 1 BOTTLE, GLASS (50419-325-74) |
50419-325-11 |
50419-325 |
HUMAN PRESCRIPTION DRUG |
Gadavist |
gadobutrol |
INJECTION |
INTRAVENOUS |
20110315 |
N/A |
NDA |
NDA201277 |
Bayer HealthCare Pharmaceuticals Inc. |
GADOBUTROL |
604.72 mg/mL |
2 CARTON in 1 BOX (50419-325-11) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 7.5 mL in 1 VIAL, SINGLE-DOSE |
50419-325-12 |
50419-325 |
HUMAN PRESCRIPTION DRUG |
Gadavist |
gadobutrol |
INJECTION |
INTRAVENOUS |
20110315 |
N/A |
NDA |
NDA201277 |
Bayer HealthCare Pharmaceuticals Inc. |
GADOBUTROL |
604.72 mg/mL |
2 CARTON in 1 BOX (50419-325-12) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE |
50419-325-13 |
50419-325 |
HUMAN PRESCRIPTION DRUG |
Gadavist |
gadobutrol |
INJECTION |
INTRAVENOUS |
20110315 |
N/A |
NDA |
NDA201277 |
Bayer HealthCare Pharmaceuticals Inc. |
GADOBUTROL |
604.72 mg/mL |
2 CARTON in 1 BOX (50419-325-13) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE |
50419-325-27 |
50419-325 |
HUMAN PRESCRIPTION DRUG |
Gadavist |
gadobutrol |
INJECTION |
INTRAVENOUS |
20110315 |
N/A |
NDA |
NDA201277 |
Bayer HealthCare Pharmaceuticals Inc. |
GADOBUTROL |
604.72 mg/mL |
5 SYRINGE, GLASS in 1 BOX (50419-325-27) / 7.5 mL in 1 SYRINGE, GLASS |
50419-325-28 |
50419-325 |
HUMAN PRESCRIPTION DRUG |
Gadavist |
gadobutrol |
INJECTION |
INTRAVENOUS |
20110315 |
N/A |
NDA |
NDA201277 |
Bayer HealthCare Pharmaceuticals Inc. |
GADOBUTROL |
604.72 mg/mL |
5 SYRINGE, GLASS in 1 BOX (50419-325-28) / 10 mL in 1 SYRINGE, GLASS |
50419-325-29 |
50419-325 |
HUMAN PRESCRIPTION DRUG |
Gadavist |
gadobutrol |
INJECTION |
INTRAVENOUS |
20110315 |
N/A |
NDA |
NDA201277 |
Bayer HealthCare Pharmaceuticals Inc. |
GADOBUTROL |
604.72 mg/mL |
5 SYRINGE, GLASS in 1 BOX (50419-325-29) / 15 mL in 1 SYRINGE, GLASS |
50419-325-37 |
50419-325 |
HUMAN PRESCRIPTION DRUG |
Gadavist |
gadobutrol |
INJECTION |
INTRAVENOUS |
20110315 |
N/A |
NDA |
NDA201277 |
Bayer HealthCare Pharmaceuticals Inc. |
GADOBUTROL |
604.72 mg/mL |
15 CARTON in 1 BOX (50419-325-37) / 3 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE |
50419-325-72 |
50419-325 |
HUMAN PRESCRIPTION DRUG |
Gadavist |
gadobutrol |
INJECTION |
INTRAVENOUS |
20110315 |
N/A |
NDA |
NDA201277 |
Bayer HealthCare Pharmaceuticals Inc. |
GADOBUTROL |
604.72 mg/mL |
10 VIAL, SINGLE-DOSE in 1 CARTON (50419-325-72) / 10 mL in 1 VIAL, SINGLE-DOSE |
50419-325-75 |
50419-325 |
HUMAN PRESCRIPTION DRUG |
Gadavist |
gadobutrol |
INJECTION |
INTRAVENOUS |
20220512 |
N/A |
NDA |
NDA201277 |
Bayer HealthCare Pharmaceuticals Inc. |
GADOBUTROL |
604.72 mg/mL |
5 SYRINGE, GLASS in 1 BOX (50419-325-75) / 10 mL in 1 SYRINGE, GLASS |